Testing the Addition of Ipatasertib to Hormonal Treatment for Recurrent or Metastatic Endometrial Cancers

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05538897

Provider View

This study is exploring whether adding the drug ipatasertib to the hormonal treatment megestrol acetate can improve outcomes for patients with endometrial cancer that has returned or spread. The trial will assess the safety, side effects, and effectiveness of this combination compared to megestrol acetate alone.

Patient Parameters

Program Overview

This clinical trial is investigating a new treatment approach for endometrial cancer that has come back or spread to other parts of the body. The study is testing whether combining ipatasertib, a drug that may stop cancer cell growth, with megestrol acetate, a hormonal treatment, is more effective than using megestrol acetate alone. The trial will evaluate the safety, side effects, and best dose of this combination treatment.

Description

The study has two main phases: Phase Ib and Phase II.

Phase Ib:

  • Patients will take megestrol acetate daily and ipatasertib for 21 days in each 28-day cycle.
  • The goal is to find the safest and most effective dose of ipatasertib when combined with megestrol acetate.
  • Patients will have regular CT or MRI scans and blood tests to monitor their health and the cancer's response.

Phase II:

  • Patients will be randomly assigned to one of two groups:
    • Group 1: Takes megestrol acetate daily.
    • Group 2: Takes both megestrol acetate and ipatasertib as in Phase Ib.
  • The study will compare how long patients live without the cancer getting worse and the side effects of the treatments.
  • Regular scans and blood tests will continue throughout the study.

After treatment, patients will have follow-up visits to monitor their health and any long-term effects of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Have grade 1 or 2 endometrial cancer that has returned or spread.
  • Have at least one tumor that can be measured by scans.
  • Have completed any previous hormonal therapy at least 6 months ago.
  • Be 18 years or older.
  • Be in good general health with a performance status of 0, 1, or 2.
  • Have adequate blood cell counts and organ function based on specific tests.
  • Women of childbearing potential must agree to use effective birth control during and after the study.
  • Be able to swallow pills and not have digestive issues that affect medication absorption.
  • Provide informed consent to participate in the study.

Exclusion Criteria

  • Have previously been treated with an AKT inhibitor.
  • Have uncontrolled diabetes or require insulin therapy.
  • Require high doses of steroids or other immunosuppressive medications.
  • Have high cholesterol or triglycerides that are not controlled.
  • Have inflammatory bowel disease or active bowel inflammation.
  • Have significant heart or liver disease.
  • Have lung disease or recent serious lung infections.
  • Have an active infection requiring IV antibiotics.
  • Be pregnant or unwilling to stop breastfeeding during the study.

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